FDA 483 - Octapharma Plasma Inc - April 27, 2022

Octapharma Plasma Inc. in Reynoldsburg, OH, was inspected by the FDA, resulting in six observations related to deviations from written standard operating procedures. The observations primarily concern improper aseptic technique during donor disconnection, incorrect donor screening and physical examination procedures, and failures in plasma processing and quality control for equipment. These issues indicate a lack of consistent adherence to established protocols for source plasma collection and processing.